L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a pris, le 11 ao\u00fbt 2026, une injonction \u00e0 l\u2019encontre de la soci\u00e9t\u00e9 Cardiop, dont l\u2019\u00e9tablissement est situ\u00e9 \u00e0 Magnieu (Ain), zone d\u2019activit\u00e9s de l\u2019Ousson Nord, 280 rue des Marais. Cette mesure administrative est fond\u00e9e sur les articles L. 5311-1, L. 5312-4-3 et L. 5313-1 du code de la sant\u00e9 publique et fait suite \u00e0 une inspection r\u00e9alis\u00e9e sur site les 6 et 7 mai 2026.<\/p>\n
L\u2019inspection a mis en \u00e9vidence des non-conformit\u00e9s importantes au regard du r\u00e8glement (UE) 2017\/745 relatif aux dispositifs m\u00e9dicaux, qui ont \u00e9t\u00e9 notifi\u00e9es \u00e0 l\u2019\u00e9tablissement dans une lettre pr\u00e9alable \u00e0 injonction en date du 1er juillet 2026. Malgr\u00e9 la r\u00e9ponse transmise par la soci\u00e9t\u00e9 le 24 juillet 2026, l\u2019ANSM consid\u00e8re que plusieurs manquements n\u2019ont pas \u00e9t\u00e9 corrig\u00e9s de mani\u00e8re satisfaisante.<\/p>\n
Les principaux points relev\u00e9s concernent : des insuffisances dans les mesures de sauvegarde et de s\u00e9curisation des donn\u00e9es de tra\u00e7abilit\u00e9, ne garantissant pas leur conservation sur la dur\u00e9e exig\u00e9e par le r\u00e8glement (article 25, paragraphes 1 et 2) ; des insuffisances dans les v\u00e9rifications de conformit\u00e9 r\u00e9glementaire des dispositifs m\u00e9dicaux distribu\u00e9s (articles 14, paragraphes 1 et 2, et 25, paragraphe 1) ; des insuffisances et incoh\u00e9rences dans les donn\u00e9es du registre des dispositifs m\u00e9dicaux non conformes, ainsi que l\u2019absence de registre des r\u00e9clamations, rappels et retraits (article 14, dernier paragraphe, et paragraphes 4, 5 et 6).<\/p>\n
Au vu de ces constats, l\u2019ANSM enjoint \u00e0 l\u2019\u00e9tablissement de se mettre en conformit\u00e9 avec les exigences du r\u00e8glement (UE) 2017\/745, afin d\u2019assurer une tra\u00e7abilit\u00e9, une surveillance et une gestion des non-conformit\u00e9s et incidents conformes au cadre r\u00e9glementaire europ\u00e9en applicable aux dispositifs m\u00e9dicaux. Cette mesure illustre le r\u00f4le de l\u2019ANSM en mati\u00e8re de contr\u00f4le et de police sanitaire des fabricants ou distributeurs de dispositifs m\u00e9dicaux en France.\u00a0(contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) a pris, le 11 ao\u00fbt 2026, une injonction \u00e0 l\u2019encontre de la soci\u00e9t\u00e9 Cardiop, dont l\u2019\u00e9tablissement est situ\u00e9 […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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